What's New on the FDA Drugs Site
February 12, 2014
- Approved Risk Evaluation and Mitigation Strategies (REMS) (Updated)
- Current Drug Shortages Index (updated)
- Drugs@FDA Data Files (updated)
- FDA approves Imbruvica (ibrutinib) to treat chronic lymphocytic leukemia
- FDA Drug Safety Podcast: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (updated)
- Spanish FDA Drug Safety Communication: Saxagliptina: La FDA analizará el riesgo de insuficiencia cardiaca con el medicamento para la diabetes saxagliptina (comercializado como Onglyza y Kombiglyze XR)
- Warning Letters 2014 (Updated)
New and Generic Drug Approvals
February 11, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acetylcysteine | acetylcysteine | Solution; Oral | Innopharma Licensing | Approval |
| Edex | alprostadil | Injectable;Injection | Actient Pharms | Manufacturing Change or Addition |
| Monistat 1 Combination Pack | miconazole nitrate | Cream, Suppository;Topical, Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Monistat 3 | miconazole nitrate | Suppository;Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Monistat 3 | miconazole nitrate | Cream;Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Monistat 3 Combination Pack | miconazole nitrate | Cream;Topical, Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Monistat 3 Combination Pack (Prefilled) | miconazole nitrate | Cream;Topical, Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Monistat Dual- Pak | miconazole nitrate | Cream, Insert; Topical, Vaginal | Personal Prods | Manufacturing Change or Addition |
| Monistat-3 Combination Pack | miconazole nitrate | Cream, Suppository;Topical, Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Monistat-Derm | miconazole nitrate | Cream;Topical | Insight Pharms | Manufacturing Change or Addition |
| Rizatriptan Benzoate | rizatriptan benzoate | Tablet;Oral | Macleods Pharms Ltd | Approval |
| Tranexamic Acid | tranexamic acid | Injectable;Injection | Acic Fine Chemicals Inc | Approval |
| Vitrase | hyaluronidase | Injectable;Injection | Bausch and Lomb | Manufacturing Change or Addition |
| Vpriv | velaglucerase alfa | Injectable;Iv (Infusion) | Shire Human Genetic | Manufacturing Change or Addition |
| Vpriv | velaglucerase alfa | Powder;Iv (Infusion) | Shire Human Genetic | Manufacturing Change or Addition |
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